Bryan Kim, Global Director of Specialties at STADA, commented: “This positive opinion from the CHMP places STADA and Alvotech in a unique position to improve patient access to the ustekinumab and interleukin inhibitor markets. As a pioneer in the festival of biosimilars, STADA seeks We are eager to offer European gastroenterologists, dermatologists and rheumatologists a valuable and cost-effective remedy option.
Joseph McClellan, Chief Scientific Officer of Alvotech, said: “Having collaborated in the past with STADA to commercialise a high-concentration adalimumab biosimilar in several European markets, Alvotech is excited to expand patient access to treatments for inflammatory conditions with our ustekinumab biosimilar.
Ustekinumab is a human IgG1κ monoclonal antibody (mAb). AVT04 was designed from the Sp2/0 host mobile line and is manufactured using an infusion process, like the Stelara reference product. Ustekinumab selectively targets the p40 protein, a common component of the cytokines IL-12 and IL-23 that play a very important role. important role in the treatment of immune-mediated diseases such as Crohn’s disease, psoriasis and psoriatic arthritis.
With approximately 95,000 patients already using ustekinumab in the top 4 EU markets plus the UK, Stelara is among the top 10 most sensible European drug brands in terms of value, with annual profit exceeding €2. 5 billion. The biosimilars festival following the expiration of Stelara’s European exclusivity rights offers a significant opportunity to simultaneously improve patient access or reduce prices to European healthcare systems. About STADA Arzneimittel AG STADA Arzneimittel AG is headquartered in Bad Vilbel, Germany. The company focuses on a three-pillar strategy that adds customer healthcare, generics and specialty pharmaceuticals. Worldwide, STADA Arzneimittel AG sells its products in around 120 countries. In fiscal year 2022, STADA obtained a business profit of 3,797. 2 million euros and an earnings before interest, taxes, depreciation and amortization (EBITDA) of 884. 7 million euros. As of December 31, 2022, STADA hired another 13,183 people worldwide. About Alvotech Alvotech is a biotechnology company founded by Robert Wessman and focused solely on the progression and production of biosimilar medicines for patients worldwide. Alvotech seeks to become a global leader in biosimilars by offering high-quality, cost-effective products and services, made possible through fully incorporated technology and extensive in-house capabilities. Alvotech’s current portfolio comprises eight biosimilar applicants for the treatment of autoimmune diseases, ocular disorders, osteoporosis, respiratory diseases and cancer. Alvotech has formed a network of strategic business partnerships to deliver global success and leverage local expertise in markets such as the United States, Europe, Japan, China and other Asian countries and major parts of South America, Africa and the Middle East. Alvotech’s commercial components are Teva Pharmaceuticals, a US subsidiary of Teva Pharmaceutical Industries Ltd. (USA), STADA Arzneimittel AG (EU), Fuji Pharma Co. , Ltd (Japan), Advanz Pharma (EEA), Cipla/ Cipla Gulf/Cipla. Medicine. Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co. , Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India , Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co. , Ltd. (Thailand, Vietnam, Philippines and South Korea). Each business component covers a unique set of products and territories. Unless otherwise indicated, Alvotech disclaims all responsibility for the content of periodic documents, disclosures and other reports made through its components. For more information, visit www. alvotech. com. None of the data on Alvotech’s online page will be considered part of this press release.
Forward-Looking Statements Certain statements contained in this release may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements sometimes relate to long-term events or long-term operational financial functionality of Alvotech and could include, for example, Alvotech’s expectations related to competitive advantages, commercial customers and opportunities, including the progression of products currently in development. . plans and intentions, effects, point of activities, functionality, objectives or achievements or other long-term occasions, regulatory review and intermovements, good fortune of your business associations, addition of your association with STADA, milestones and payment invoices, potential royalties, potential approval and publicity. launch of its product candidates, the timing of regulatory approvals and market position launches, additions in Europe and the estimated duration of the overall addressable market position for Alvotech’s existing products, and the advertising good fortune of AVT04, in Europe and other parts of the world. Alvotech’s ability to improve global access to affordable biologics and the effect of biosimilars on inflationary pressures for healthcare systems. In some cases, you can identify forward-looking statements by terms such as “possibly”, “would”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”. “forward-looking”, “target” or “continue”, or the negative terminology of those terms or their diversifications or similar terminology. These forward-looking statements are subject to risks, uncertainties and other matters that may also cause actual effects to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based on estimates and assumptions that, while considered conservative by Alvotech and its management, are inherently doubtful and are inherently subject to hazards, variations and unforeseen events, many of which are beyond the control of Alvotech. They may also cause actual effects to differ materially from existing expectations including, but not limited to: (1) the ultimate results of any legal proceedings that would possibly be brought against Alvotech or others as a result of the business combination . corporations between Alvotech Holdings S. A. and Oaktree Acquisition Corp. II and Alvotech; (2) adjustments in applicable legislation or regulations; (3) the option that Alvotech could possibly have adverse effects through other economic, commercial and/or competitive points; (4) Alvotech’s earnings and expense estimates; (5) Alvotech’s ability to develop, manufacture and advertise its product pipeline and product candidates, adding AVT04; (6) moves by regulatory authorities, which would likely have effects on the initiation, timing and progress of clinical studies or long-term regulatory approvals or market positioning clearances; (7) the ability of Alvotech or its partners to respond to inspection findings and deficiencies to the satisfaction of regulators; (8) the ability of Alvotech or its partners to recruit and retain patients in clinical studies; (9) the ability of Alvotech or its partners to obtain regulatory approval for planned clinical studies, designs or examination sites; (10) the ability of Alvotech’s partners to conduct, supervise and monitor existing and future long-term clinical studies, which would potentially have an effect on timelines and progression plans; (11) Alvotech’s ability to discharge and maintain regulatory approval or clearances for its products, adding AVT04, adding timing or likelihood of expansion to other market positions or geographies; (12) the good fortune of Alvotech’s existing and long-term collaborations, joint ventures, partnerships or licensing agreements, including the partnership with STADA; (13) the ability of Alvotech and its business partners to execute their advertising strategy for approved products, adding AVT04; (14) Alvotech’s ability to manufacture a sufficient advertising source for its approved products, adding AVT04; (15) the final results of pending and long-term litigation relating to Alvotech’s products and product candidates; (16) the potential impact of the ongoing COVID-19 pandemic on FDA review schedules, including its ability to conduct timely inspections of production sites; and (17) other dangers and concerns set forth in the sections titled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may file with or provide from time to time to the SEC. There may be other dangers that Alvotech is not aware of or that Alvotech considers insignificant and that could also cause actual effects to differ from those contained in the forward-looking statements. Nothing in this communication should be construed as a representation by any user that the forward-looking statements set forth herein will be achieved or that any of the intended effects of such forward-looking statements will be achieved. You deserve not to place undue reliance on forward-looking statements, which speak only as of the date they are made. Alvotech assumes no legal responsibility to update such forward-looking statements or to inform the recipient of any matter of which any of them is aware that may also have an effect on any matter discussed in this communication. Alvotech assumes no liability for any loss or damage (whether foreseeable or otherwise) suffered or incurred by any user or entity as a result of anything contained in or overlooked in this communication and such liability is expressly disclaimed. Recipient agrees not to sue or hold Alvotech or any of its directors, officers, employees, affiliates, agents, advisors or representatives liable in any respect for the provision of this communication, the data contained in this communication or the omission of any data in this communication.
STADA data for journalists: STADA Arzneimittel AG – Media RelationsStadastrasse 2-1861118 Bad Vilbel – Germany Phone: 49 (0) 6101 603-165E-Mail: press@stada. de Or us on the Internet at www. stada. com/ press address
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